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Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03361345
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

Brief Summary:
The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.

Condition or disease Intervention/treatment Phase
Postinflammatory Hyperpigmentation Drug: Tranexamic Acid Drug: Vehicle Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-face study in which topical tranexamic acid will be applied to one side of the face and the other side of the face will be the placebo/vehicle as a control.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Right Side of Face
Patients will apply topical tranexamic acid to the dark spots on the one side of their face.
Drug: Tranexamic Acid
Topical tranexamic acid in cream form applied to dark spots on right side of face.

Sham Comparator: Left Side of Face
Patients will apply the vehicle cream without any medication to the dark spots on one side of their face.
Drug: Vehicle
The Vehicle is going to be a cream without any active medication that will be applied as a control substance for the topical tranexamic acid cream, and will be applied to the contralateral side of the face.




Primary Outcome Measures :
  1. Change from Baseline Pigmentation at 4 Weeks. [ Time Frame: 4 Weeks. ]

    Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 4 weeks.

    The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.


  2. Change from Baseline Pigmentation at 8 Weeks. [ Time Frame: 8 Weeks ]

    Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 8 weeks.

    The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.


  3. Change from Baseline Pigmentation at 12 Weeks. [ Time Frame: 12 Weeks ]

    Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 12 weeks.

    The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 65
  • Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris.

Exclusion Criteria:

  • Pregnant patients or patients planning to become pregnant during the time of the study.
  • Patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361345


Contacts
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Contact: Steven D Daveluy, MD 5198195868 sdaveluy@med.wayne.edu
Contact: Emma Reaves 3134297845 az3432@wayne.edu

Locations
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United States, Michigan
WSUPG Dermatology Recruiting
Dearborn, Michigan, United States, 48124
Contact: Steven D Daveluy    313-429-7854    sdaveluy@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Steven Daveluy WSUPG Dermatology
  Study Documents (Full-Text)

Documents provided by Steven D Daveluy, Wayne State University:
Publications:

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Responsible Party: Steven D Daveluy, Program Director of Wayne State University Department of Dermatology, Wayne State University
ClinicalTrials.gov Identifier: NCT03361345    
Other Study ID Numbers: 1709000866
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steven D Daveluy, Wayne State University:
Postinflammatory hyperpigmentation
Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Hyperpigmentation
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pigmentation Disorders
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants